The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights

Malbon, Justin; Lawson, Charles; Davison, Mark

doi:10.4337/9781781006047

Cited by 50 publications

(17 citation statements)

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“…Patents are issued by federal governments and they give the patent holder the right to determine the conditions under which the patented object, process, trait or entity may be used by others for commercial or research purposes; the right is time de-limited. Nations can and do place limits on the patent holder's rights for the sake of protecting public health or public order/welfare (Malbon et al, 2014). 21.…”

Section: Resultsmentioning

confidence: 99%

Autonomy of Nations and Indigenous Peoples and the Environmental Release of Genetically Engineered Animals with Gene Drives

Meghani

2019

Global Policy

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This article contends that the environmental release of genetically engineered (GE) animals with heritable traits that are patented will present a challenge to the efforts of nations and indigenous peoples to engage in self-determination. The environmental release of such animals has been proposed on the grounds that they could function as public health tools or as solutions to the problem of agricultural insect pests. This article brings into focus two political-economic-legal problems that would arise with the environmental release of such organisms. To address those challenges, it is proposed that nations considering the environmental release of GE animals must take into account the underlying circumstances and policy failures that motivate arguments for the use of the modified animals. Moreover, countries must recognize that the UN International Covenant on Civil and Political Rights and the UN International Covenant on Economic, Social and Cultural Rights place on them an obligation to ensure that GE animals with patented heritable traits are not released without the substantive consent of the nations or indigenous peoples that could be affected. Policy Implications • Nations considering the environmental release of genetically engineered (GE) animals with patented heritable traits must take into account the underlying circumstances and policy failures that motivate arguments for the use of the modified organisms.

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Section: Resultsmentioning

confidence: 99%

Autonomy of Nations and Indigenous Peoples and the Environmental Release of Genetically Engineered Animals with Gene Drives

Meghani

2019

Global Policy

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“…Consistent with these obligations both the CBD and Nagoya Protocol also make express provision respecting that access and transfer of technology “shall be provided on terms which recognize and are consistent with the adequate and effective protection of intellectual property” (CBD: Art 16.2; Nagoya Protocol, Art 4.4). The effect of these provisions is to accept the existing measures regulating information under the World Trade Organisation's Trade‐Related Aspects of Intellectual Property Rights (TRIPS) (TRIPS, ) in the form of confidential information, trade secrets, and undisclosed information used in regulatory decision making about pharmaceutical and agricultural chemical products (Art 39; see Malbon, Lawson, & Davison, , pp. 571–595).…”

Section: Information Sharing Obligationsmentioning

confidence: 99%

“…Further, the Plant Treaty's objectives are intended to be “closely linked” with the CBD (and Nagoya Protocol; Art 1.2). Again, the effect of these provisions is to accept the existing measures regulating confidential information, trade secrets, and undisclosed information used in regulatory decision making about pharmaceutical and agricultural chemical products under TRIPS (Art 39; see Malbon et al, , pp. 571–595).…”

Section: Information Sharing Obligationsmentioning

confidence: 99%

The future of information under the CBD, Nagoya Protocol, Plant Treaty, and PIP Framework

Lawson

Humphries

Rourke

2019

World Intellectual Property

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The United Nations’ Convention of Biological Diversity (and the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization), the Food and Agriculture Organisation of the United Nations’ International Treaty for Plant Genetic Resources for Food and Agriculture, and the World Health Organisation of the United Nations’ (WHO) Pandemic Influenza Preparedness Framework all set out schemes for access and benefit sharing (ABS) some biological materials. This article addresses the apparent conflict between the general obligations in these agreements to disclose and exchange information and dealing with information as a resource derivative within the ABS transaction. This latter dealing is a closed domain for information under the ABS schemes where information is a resource derivative that is a part of the ABS transaction. Treating information as a resource derivative within the ABS transaction is likely to impose unnecessary and inefficient burdens on ABS transactions. After reviewing the recent developments, the article postulates a risk framework for valuing information as a part of the ABS transaction, or alternatively, a charge, tax, or levy to externalize the costs so that information remains available to be disclosed and exchanged promoting more and better science and research.

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“…The language of the TRIPS does not offer any preferential indication, since different provisions utilize the expression “new” either in an absolute or relative connotation (Skillington & Solovy, 2004, p. 26; Shaikh, , p. 102) . Driven by this ambiguity, several commentators conclude that the provision defers to contradicting parties the task of more precisely defining the expression in patent or regulatory terms (Basheer, , p. 32; Malbon, Lawson, & Davidson, , p. 583; Owoeye, , p. 583; Roffe et al, , p. 530; Sharma, , p. 89).…”

Section: Requirements For Protectionmentioning

confidence: 99%

“…Some suggest that the efforts should not be evaluated exclusively from an economical perspective, but also under a scientific and technical one (Basheer, , p. 33; Owoeye, , p. 11). This opinion appears rather ambiguous considering that clinical trials are obtained through standard procedures, and therefore constitute an effort that from a scientific point of view is more the fruit of routine rather than of a considerable technical or intellectual endeavor (Correa, , p. 18; Malbon et al, , p. 585). Most importantly, the technical or scientific complexity of a trial has little to do with its unfair exploitation by competitors.…”

Section: Requirements For Protectionmentioning

confidence: 99%

The 13th Round: Article 39(3) TRIPS and the struggle over “Unfair Commercial Use”

Alì

2018

World Intellectual Property

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Property Rights (TRIPS) was the first international agreement to provide for some form of protection for regulatory information submitted by companies in order to obtain marketing authorization for a pharmaceutical product.Nevertheless, after more than 20 years from the formation of the agreement, the ultimate meaning of Article 39 (3) thereof remains contentious among scholars and governments. In detail, it is still debated whether the provision mandates for some form of protection against the practice to authorize generic drugs by relying upon the clinical dossier submitted by drug developers or if it tackles otherwise unlawful conducts as data theft and espionage in the pharmaceutical sector. By reassessing the relevant literature on the topic, and by combining old and new arguments, the present paper argues that Article 39(3) does address regulatory reliance practices. However, it also emphasizes that the impact of the provision on developing countries pharmaceutical policies is greatly mitigated by the flexibility left to WTO members to approve generic drugs by referring to prior foreign authorizations. Finally, the paper concludes by reflecting on an issue often overlooked by commentators, that is, the amount of protection necessary to comply with Article 39(3).

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The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights

Cited by 50 publications

References 0 publications

Autonomy of Nations and Indigenous Peoples and the Environmental Release of Genetically Engineered Animals with Gene Drives

Autonomy of Nations and Indigenous Peoples and the Environmental Release of Genetically Engineered Animals with Gene Drives

The future of information under the CBD, Nagoya Protocol, Plant Treaty, and PIP Framework

The 13th Round: Article 39(3) TRIPS and the struggle over “Unfair Commercial Use”

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